Whitepaper: The necessity of E&L qualifications for lyophilised drug products
Posted: 4 February 2021 | Nelson Laboratories LLC | No comments yet
Lyophilised drug product containers and administration devices consist of the primary packaging, the reconstitution solution container, and the drug administration set.
Lyophilised drug product containers and administration devices consist of the primary packaging (typically a glass vial and a rubber stopper), the reconstitution solution container (typically a vial or a prefilled syringe system), and the drug administration set (such as a disposable syringe, an intravenous bag, or a pump system with administration tubing) as shown in the Whitepaper.
Related content from this organisation
- Unmasking the unknown: how mass spectrometry delivers accurate identifications
- Review: Good identification practices for organic extractables and leachables via mass spectrometry
- On-demand webinar: Testing disinfectant agents for antimicrobial action on hard surfaces
- On-demand webinar: Key elements of a sterility assurance program
- Whitepaper: Why extractables and leachables matter
Related topics
Analytical techniques, Biologics, Biopharmaceuticals, Bioprocessing, Endotoxin, Excipients, Formulation, Good Manufacturing Practice (GMP), Labelling, Manufacturing, Medical Devices, Microbiology, Outsourcing, Packaging, QA/QC, Regulation & Legislation, Research & Development (R&D), Supply Chain
